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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Metrics-driven quality improvement (MDQI)

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.

• Study Type: Interventional
• Enrollment (Estimated): 7950
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan O'Grady, PhD; Phone Number: 860-679-5483; Email: ogrady@uchc.edu
• Study Contact Backup: Name: Charles Neighbors, PhD; Phone Number: 646-501-3875; Email: Charles.Neighbors@nyulangone.org

Study Locations

• United States
  • New York
    • Blauvelt, New York, United States, 10913
      • Recruiting
      • Samaritan Rockland - Outpatient Program
      • Contact: Carolann Slattery; Email: carolann.slattery@samaritanvillage.org
      • Principal Investigator: Charles Neighbors, PhD
    • Jamaica, New York, United States, 11435
      • Recruiting
      • Samaritan Queens - Jamaica IOP
      • Contact: Carolann Slattery; Email: carolann.slattery@samaritanvillage.org
      • Principal Investigator: Charles Neighbors, PhD
    • New York, New York, United States, 10027
      • Recruiting
      • Samaritan Daytop Village Harlem - Outpatient Program
      • Contact: Carolann Slattery; Email: carolann.slattery@samaritanvillage.org
      • Principal Investigator: Charles Neighbors, PhD
    • New York, New York, United States, 10031
      • Recruiting
      • Upper Manhattan Addiction Treatment Services Program
      • Contact: Kristy Rodriguez; Email: krodriguez@bowencsc.org
      • Principal Investigator: Charles Neighbors, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Metrics-driven quality improvement (MDQI) intervention	Behavioral: Metrics-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of treatment	Cost of the intervention to the clinic	Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic-level rates of clients with Severe OUD	As indicated by daily use and/or injection drug use as indicated in state administrative admission data	Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic level-rates of clients identified as homeless	As indicated in state administrative admission data	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA); UConn Health; New York State Office of Addiction Services and Supports
• Investigators: Principal Investigator: Charles Neighbors, PhD, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 20-00776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article resulting from surveys only, after deidentification (text, tables, figures, and appendices), will be available. Client outcome data from State administrative data files will not be available for sharing due to the nature of the data security agreements.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No