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

Health Services Research Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408233
• Other study ID #: 23-00896
• Secondary ID: 1RM1DA059377-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2028

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Charles Neighbors, PhD
• Phone: 646-501-3879
• Email: Charles.Neighbors[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Health Services Research

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of substance use related emergency department visits		Baseline (6 months prior to intervention), 6 months post-intervention
Primary	Change in number of substance use related hospitalizations		Baseline (6 months prior to intervention), 6 months post-intervention
Primary	Change in mortality rate		Baseline (6 months prior to intervention), 6 months post-intervention