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

NCT ID: NCT04632238

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Opioid-use Disorder Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped Wedge Cluster Randomized Trial (SW-RCT)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Metrics-driven quality improvement (MDQI) intervention

Group Type EXPERIMENTAL

Metrics-driven quality improvement (MDQI)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Office of Addiction Services and Supports

UNKNOWN

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Neighbors, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Samaritan Rockland - Outpatient Program

Blauvelt, New York, United States

Site Status

Samaritan Queens - Jamaica IOP

Jamaica, New York, United States

Site Status

Samaritan Daytop Village Harlem - Outpatient Program

New York, New York, United States

Site Status

Upper Manhattan Addiction Treatment Services Program

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33413493 (View on PubMed)

Other Identifiers

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20-00776

Identifier Type: -

Identifier Source: org_study_id

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