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Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid

Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04632238
Enrollment
7950
Registered
2020-11-17
Start date
2020-07-01
Completion date
2025-06-30
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder, Substance Use Disorders

Brief summary

This project will develop and test quality measures for and a facilitation model to help addictions treatment clinics increase use of medicines for opioid use disorders, retain clients longer in care, and help more people move into successful recovery. At the end of the project, we will have developed specific training and coaching protocols as well as electronic clinical support tools to guide quality improvement that can be disseminated within New York and the rest of the country. The study will test a clinic-level intervention that uses external facilitators to provide guidance to addictions clinics and contain three key components: 1) training on data driven management; 2) training and guidance on patient-centered care and OUD medication; and 3) electronic tools for shared decision making and patient progress monitoring.

Detailed description

There will be 4 sources of data examined in this study: 3 at the patient level and 1 at the staff level. The sources of patient data include: 1) State administrative data from all clients receiving treatment at the enrolled clinics (\ 7,950); 2) a subsample (1,200) who will be recruited directly from the clinics to complete patient-reported outcome assessments, and 3) treatment progress data for clients will also be collected. For our administrative source of data, a final study population of approximately 7,950 individuals who are receiving treatment in the 30 enrolled outpatient treatment clinics for OUD is anticipated. Clinics will be located in the New York City metropolitan region (including Nassau, Westchester, and Rockland counties) and the Capital Region (including Albany, Rensselaer, Saratoga, Montgomery, Schenectady, and Schoharie counties). Staff at each enrolled clinic will also be interviewed and surveyed.

Interventions

BEHAVIORALMetrics-driven quality improvement (MDQI)

The intervention broadly consists of training and coaching to clinic staff and leadership on 1) clinical quality measure monitoring; 2) clinical practice process change management; and 3) use of tools for shared decision making and patient treatment progress monitoring.

Sponsors

NYU Langone Health
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
New York State Office of Addiction Services and Supports
CollaboratorUNKNOWN
UConn Health
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Stepped Wedge Cluster Randomized Trial (SW-RCT)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Substance use disorder clinics in the regions surrounding New York City and the New York Capital Region with annual census of 50 or greater. * All staff and patients from participating clinics will be eligible to participate in the study. * Inclusion in the analyses using administrative data will be limited to those enrolled in Medicaid and not co-insured with Medicare (individuals ages greater than 64 and those with Federally determined disability).

Exclusion criteria

* Patients who are not working/being treated at substance use disorder clinics with less than 50 clients per year.

Design outcomes

Primary

MeasureTime frameDescription
Change in clinic-level rates of initiation to OUD medicationsAssessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in clinic-level rates of adherence to OUD medicationsAssessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Retention in CareAssessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.Clinic rates of 6-month client retention in care
Change in Incidence of OverdosesAssessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Incidence of Substance Use-Related Hepatitis C InfectionAssessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Number of Emergency Room VisitsAssessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Health StatusAssessed from the start of each clinic in the intervention to 1 year post-interventionChange in health status is measured by the first item of the SF-12 Health Survey: "In general, would you say your health is: 1 - excellent, 2 - very good, 3 - good, 4 - fair, 5 - poor". Scores range from 1-5, with a higher score indicating worse health.

Secondary

MeasureTime frameDescription
Cost of treatmentAssessed from commencement of the intervention at each clinic to 1 year post-interventionCost of the intervention to the clinic
Change in clinic-level rates of clients with Severe OUDAssessed from commencement of the intervention at each clinic to 1 year post-interventionAs indicated by daily use and/or injection drug use as indicated in state administrative admission data
Change in clinic level-rates of clients identified as homelessAssessed from commencement of the intervention at each clinic to 1 year post-interventionAs indicated in state administrative admission data
Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission dataAssessed from commencement of the intervention at each clinic to 1 year post-intervention

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCharles Neighbors, PhD

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026