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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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