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

Primary Purpose

Opioid-use Disorder, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metrics-driven quality improvement (MDQI)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Samaritan Rockland - Outpatient ProgramRecruiting
  • Samaritan Queens - Jamaica IOPRecruiting
  • Samaritan Daytop Village Harlem - Outpatient ProgramRecruiting
  • Upper Manhattan Addiction Treatment Services ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Metrics-driven quality improvement (MDQI) intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in clinic-level rates of initiation to OUD medications
Change in clinic-level rates of adherence to OUD medications
Retention in Care
Clinic rates of 6-month client retention in care
Change in Incidence of Overdoses
Change in Incidence of Substance Use-Related Hepatitis C Infection
Change in Number of Emergency Room Visits
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.

Secondary Outcome Measures

Cost of treatment
Cost of the intervention to the clinic
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
Change in clinic level-rates of clients identified as homeless
As indicated in state administrative admission data
Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission data

Full Information

First Posted
November 12, 2020
Last Updated
March 29, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA), New York State Office of Addiction Services and Supports, UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT04632238
Brief Title
Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
Official Title
Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA), New York State Office of Addiction Services and Supports, UConn Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Substance Use Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped Wedge Cluster Randomized Trial (SW-RCT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Metrics-driven quality improvement (MDQI) intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Metrics-driven quality improvement (MDQI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in clinic-level rates of initiation to OUD medications
Time Frame
Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Title
Change in clinic-level rates of adherence to OUD medications
Time Frame
Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Title
Retention in Care
Description
Clinic rates of 6-month client retention in care
Time Frame
Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Title
Change in Incidence of Overdoses
Time Frame
Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Title
Change in Incidence of Substance Use-Related Hepatitis C Infection
Time Frame
Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Title
Change in Number of Emergency Room Visits
Time Frame
Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Title
Change in Health Status
Description
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.
Time Frame
Assessed from the start of each clinic in the intervention to 1 year post-intervention
Secondary Outcome Measure Information:
Title
Cost of treatment
Description
Cost of the intervention to the clinic
Time Frame
Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Title
Change in clinic-level rates of clients with Severe OUD
Description
As indicated by daily use and/or injection drug use as indicated in state administrative admission data
Time Frame
Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Title
Change in clinic level-rates of clients identified as homeless
Description
As indicated in state administrative admission data
Time Frame
Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Title
Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission data
Time Frame
Assessed from commencement of the intervention at each clinic to 1 year post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Neighbors, PhD
Phone
646-501-3875
Email
Charles.Neighbors@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Megan O'Grady, PhD
Phone
860-679-5483
Email
ogrady@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Neighbors, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samaritan Rockland - Outpatient Program
City
Blauvelt
State/Province
New York
ZIP/Postal Code
10913
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolann Slattery
Email
carolann.slattery@samaritanvillage.org
First Name & Middle Initial & Last Name & Degree
Charles Neighbors, PhD
Facility Name
Samaritan Queens - Jamaica IOP
City
Jamaica
State/Province
New York
ZIP/Postal Code
11435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolann Slattery
Email
carolann.slattery@samaritanvillage.org
First Name & Middle Initial & Last Name & Degree
Charles Neighbors, PhD
Facility Name
Samaritan Daytop Village Harlem - Outpatient Program
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolann Slattery
Email
carolann.slattery@samaritanvillage.org
First Name & Middle Initial & Last Name & Degree
Charles Neighbors, PhD
Facility Name
Upper Manhattan Addiction Treatment Services Program
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristy Rodriguez
Email
krodriguez@bowencsc.org
First Name & Middle Initial & Last Name & Degree
Charles Neighbors, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33413493
Citation
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.
Results Reference
derived

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

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