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

NCT04632238 | Completed

• 1 other identifier: 20-00776
• Study Type: interventional
• Target: 7,950
• Locations: 1 country
• Sites: 4

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.

Conditions

Opioid-use Disorder; Substance Use Disorders

Outcome Measures

Primary Outcomes (7)

• Change in clinic-level rates of initiation to OUD medications

  Assessed 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 medications

  Assessed 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 Care

  Clinic rates of 6-month client retention in care

  Assessed 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 Overdoses

  Assessed 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 Infection

  Assessed 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 Visits

  Assessed 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 Status

  Change 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.

  Assessed from the start of each clinic in the intervention to 1 year post-intervention

Secondary Outcomes (4)

• Cost of treatment

  Assessed from commencement of the intervention at each clinic to 1 year post-intervention

• Change in clinic-level rates of clients with Severe OUD

  Assessed from commencement of the intervention at each clinic to 1 year post-intervention

• Change in clinic level-rates of clients identified as homeless

  Assessed from commencement of the intervention at each clinic to 1 year post-intervention

• Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission data

  Assessed from commencement of the intervention at each clinic to 1 year post-intervention

Study Arms (2)

Control

NO INTERVENTION

Metrics-driven quality improvement (MDQI) intervention

EXPERIMENTAL

Behavioral: Metrics-driven quality improvement (MDQI)

Interventions

Metrics-driven quality improvement (MDQI) BEHAVIORAL

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.

Metrics-driven quality improvement (MDQI) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator
• New York State Office of Addiction Services and Supports: collaborator
• UConn Health: collaborator

Study Sites (4)

Samaritan Rockland - Outpatient Program

Blauvelt, New York, 10913, United States

Location

Samaritan Queens - Jamaica IOP

Jamaica, New York, 11435, United States

Location

Samaritan Daytop Village Harlem - Outpatient Program

New York, New York, 10027, United States

Location

Upper Manhattan Addiction Treatment Services Program

New York, New York, 10031, United States

Location

Related Publications (1)

• O'Grady MA, Lincourt P, Greenfield B, Manseau MW, Hussain S, Genece KG, Neighbors CJ. A facilitation model for implementing quality improvement practices to enhance outpatient substance use disorder treatment outcomes: a stepped-wedge randomized controlled trial study protocol. Implement Sci. 2021 Jan 7;16(1):5. doi: 10.1186/s13012-020-01076-x.

  PMID: 33413493 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Charles Neighbors, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Stepped Wedge Cluster Randomized Trial (SW-RCT)

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 17, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Charles.Neighbors@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (4)